Glenmark specialty receives NDA approval by the US FDA

Ryaltris nasal spray for the treatment of symptoms of seasonal allergic rhinitis in adults and pediatric patients 12 years of age and older

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Glenmark
Glenmark specialty SA (Switzerland) receives NDA approval by the US food and drug administration (FDA) for Ryaltris nasal spray for the treatment of symptoms of seasonal allergic rhinitis in adults and pediatric patients 12 Years of age and older.

Ryaltris is a metered, fixed-dose, aqueous suspension, prescription drug product nasal spray approved by the FDA for the treatment of symptoms of seasonal allergic rhinitis in adults and pediatric patients 12 years of age and older. Ryaltris will be marketed and distributed in the US through their partner Hikma Specialty US, Columbus, OH.

Glenmark Pharmaceuticals, a research-led, global integrated pharmaceutical company announced that its fully owned subsidiary Glenmark Specialty SA (Switzerland), received FDA approval on its New Drug Application (NDA) for Ryaltris, an innovative, fixed-dose (metered), prescription, combination drug product nasal spray for the treatment of symptoms of seasonal allergic rhinitis in adults and pediatric patients 12 years of age and older in the US.

The FDA’s approval of Ryaltris represents a major milestone for Glenmark and clearly supports our efforts to bring innovative treatment options in our key therapeutic areas,” said Robert Crockart, chief commercial officer of Glenmark Pharmaceuticals. “With this NDA approval, we look forward to bringing this new medicine to physicians and their patients for the treatment of symptoms of seasonal allergic rhinitis, including nasal and ocular symptoms.”

Ryaltris will be marketed and distributed in the United States (US) by Hikma Specialty US, as part of its exclusive licensing agreement with Glenmark Specialty SA (Switzerland).

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